As published in Pharma's Almanac Q4 2015.
As the pharmaceutical and biotechnology markets undergo significant changes, companies are relying more heavily on CROs and CMOs to provide the needed services, expertise, and technologies to help them favorably compete in a challenging marketplace. Contract service providers, in turn, are strengthen- ing their capabilities to satisfy current demands, in some cases by coming together. An example is the recent combining of AAIPharma and Cambridge Major Laboratories, forming a full-service global CDMO supplying drug substance and drug product development, manufacturing, testing, and packaging services. This coupling also supports drug sponsors facing the escalating challenges of developing and manufacturing parenteral drug products.
Contract development and manufacturing organizations (CDMOs) have been vigorously bolstering their capabilities to support the changing needs of pharmaceutical and biotechnology companies as the industry continues its transformation over the last few years. Pressures to reduce time and costs, expand product pipelines faster, and meet more stringent regulatory requirements are key drivers of the change. They are also triggering the continued growth of outsourcing, which is increasingly considered a strategic imperative. The greater demand for outsourced services is attributed in large part to the increase in outsourcing biopharmaceutical drugs, by both pharmaceutical and biopharmaceutical companies.
This article discusses industry trends and issues in the development and manufacturing of parenteral drugs and why more drug sponsors are relying on outsourcing partners to design and implement these increasingly complex programs.